- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01090700
TMC435-TiDP16-C112 - Interaction Trial With Antidepressants
April 8, 2013 updated by: Tibotec Pharmaceuticals, Ireland
A Phase I, Open-label, Randomized, 3-way Crossover Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC435 and Escitalopram at Steady-state
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 150mg q.d.
(once a day) on the steady-state pharmacokinetics of escitalopram 10 mg q.d., and vice versa.
Steady state is a term which means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose.
TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection.
Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
TMC435 is being investigated for treatment of chronic HCV infection, in combination with Peg-IFN (pegylated interferon) and RBV (ribavirin).
Peg-IFN plus RBV are currently an accepted methods for treating HCV.
Treatment with Peg-IFN plus RBV for HCV infection is associated with a high rate of depression.
The results of this study will provide dosing recommendations for coadministration of TMC435 and escitalopram in HCV-infected patients.
This is a Phase I, open-label (both participant and investigator know the name of the medication) , randomized (study medication assigned by chance), crossover trial in 18 healthy participants to investigate the pharmacokinetic interaction between escitalopram and TMC435, both at steady state.
Steady state is a term which means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose.
The participants will receive three treatments (treatment A-B-C) in a randomized order.
In Treatment A, participants will receive TMC435 150 mg q.d.
In Treatment B, participants will receive escitalopram 10 mg q.d.
In treatment C, participants will receive escitalopram 10 mg q.d. and TMC435 150 mg q.d.
All treatments will be administered for 7 days and with food.
There will be a washout period (a period where no treatment will be taken in view of having all the medication eliminated from the body before starting a new treatment) of at least 10 days between last intake of study medication in one session and first intake of study medication in the subsequent session.
Pharmacokinetic profiles of the two compounds will be measured through blood samples taken at regular intervals during the study and safety and tolerability will be assessed during the study period and in follow-up.
Safety and tolerability evaluations will be recorded at regular intervals throughout the trial period.
Blood and urine samples, electrocardiogram (ECG) and vital signs (blood pressure and heart rate) will be taken at screening, before medication intake on days 1 and 7 and on Day 8 in each session and at the 2 follow up visits at 1 week and 4-5 weeks after last dose of drug in the last session.
A physical examination will be performed at screening, on day -1 (= day before day of first medication intake in each session) and during the 2 follow up visits.
On the morning before first medication intake (in the first session only) a blood sample will be taken to examine your CYP2C19 genes, which are responsible for the production of enzymes that determine the breakdown of drugs in your body.
The results of this study will provide dosing recommendations for coadministration of TMC435 and escitalopram in HCV-infected patients.
Participants will receive in treatment A TMC435 150 mg q.d., in treatment B participants will receive escitalopram 10 mg and in treatment C participants will receive escitalopram 10 mg q.d.
+ TMC435 150 mg q.d.
All treatments will be administered for 7 days and with food.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Non-smokers for at least 3 months prior to screening
- Healthy on the basis of physical examination, medical history, vital signs and 12-lead ECG performed at screening
- Healthy on the basis of clinical laboratory tests performed at screening
- Subjects must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
- Participants must have signed the ICF for pharmacogenetic research indicating willingness to participate in the pharmacogenetic component of the study.
Exclusion Criteria:
- A positive human immunodeficiency virus - type 1 (HIV-1) or HIV-2 test at study screening
- Hepatitis A, B, or C infection (confirmed by hepatitis A antibody immunoglobulin [IgM], hepatitis B surface antigen, or hepatitis C virus antibody, respectively) at screening
- History of liver or renal (estimated creatinine clearance below 60 mL/min) insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric and neoplastic or metabolic disturbances
- Known allergies, hypersensitivity, or intolerance to TMC435 or its excipients
- Received an investigational drug (including investigational vaccines) or used an investigational medical device within 60 days before the planned start of treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001
TMC435 TMC435 150 mg daily for 7 days
|
TMC435 150 mg daily for 7 days
|
Other: 002
Escitalopram Escitalopram 10 mg daily for 7 days
|
Escitalopram 10 mg daily for 7 days
|
Experimental: 003
TMC435 + Escitalopram TMC435 150 mg + escitalopram 10 mg daily for 7 days
|
TMC435 150 mg + escitalopram 10 mg daily for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To investigate the effect of stable blood levels of TMC 435 given 150 mg q.d. on the stable blood levels of escitalopram given 10 mg q.d. in healthy participants and vica versa.
Time Frame: pk profiles of TMC435 will be measured up to 24 hours on Day 7 in Treatment A and C. Pharmacokinetic profiles of escitalopram will be measured up to 24 hours postdose on Day 7 of Treatment B and C.
|
pk profiles of TMC435 will be measured up to 24 hours on Day 7 in Treatment A and C. Pharmacokinetic profiles of escitalopram will be measured up to 24 hours postdose on Day 7 of Treatment B and C.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The short-term safety and tolerability of coadministration of TMC435 and escitalopram in healthy participants (safety and tolerability criteria are the activity of the heart, blood pressure, pulse, physical examination, parameters in urine and blood)
Time Frame: This will be determined throughout the study; Day-1 through Day 8 in each session, 1 week and 4-5 weeks after last medication intake
|
This will be determined throughout the study; Day-1 through Day 8 in each session, 1 week and 4-5 weeks after last medication intake
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
March 11, 2010
First Submitted That Met QC Criteria
March 18, 2010
First Posted (Estimate)
March 22, 2010
Study Record Updates
Last Update Posted (Estimate)
April 9, 2013
Last Update Submitted That Met QC Criteria
April 8, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis
- Hepatitis C
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Antiviral Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Citalopram
- Dexetimide
- Simeprevir
Other Study ID Numbers
- CR017044
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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